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510(k) K093064

TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560 by Somatex Medical Technologies GmbH — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2010
Date Received
September 30, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Radiographic, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

Other clearances by Somatex Medical Technologies GmbH

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  • K111692 — TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC (November 8, 2011)
  • K102771 — BIOPSY HANDY, MRI BIOPSY HANDY (June 24, 2011)
  • K073095 — TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560 (March 19, 2008)

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